Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility)

Irene J. Higginson; Andrew Wilcock; Miriam J. Johnson; Sabrina Bajwah; Natasha Lovell; Deokhee Yi; Simon P. Hart; Vincent Crosby; Heather Poad; David Currow; Emma Best; Sarah Brown; BETTER-B Feasibility Trial Group; I Higginson; Jackie Pullen; Katie Neville; Victoria Hiley; Vicky Liversedge; Sarah Brown; Avie-Lee Tillotson; Natasha Lovell; Miriam J. Johnson; Andrew Wilcock; David Currow; Deokhee Yi; M Paine

doi:10.1136/thoraxjnl-2019-213879

Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility)

Irene J. Higginson, Andrew Wilcock, Miriam J. Johnson, Sabrina Bajwah, Natasha Lovell, Deokhee Yi, Simon P. Hart, Vincent Crosby, Heather Poad, David Currow, Emma Best, Sarah Brown, BETTER-B Feasibility Trial Group, I Higginson, Jackie Pullen, Katie Neville, Victoria Hiley, Vicky Liversedge, Sarah Brown, Avie-Lee TillotsonNatasha Lovell, Miriam J. Johnson, Andrew Wilcock, David Currow, Deokhee Yi, M Paine

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Abstract

New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score ≥3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated. Trial registration: ISRCTN 32236160; European Clinical Trials Database (EudraCT no: 2015-004064-11).

Original language	English
Pages (from-to)	176-179
Number of pages	4
Journal	Thorax
Volume	75
Issue number	2
DOIs	https://doi.org/10.1136/thoraxjnl-2019-213879
Publication status	Published - Feb 2020

Bibliographical note

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Keywords

COPD exacerbations
COPD pharmacology
drug reactions
emphysema
idiopathic pulmonary fibrosis
lung cancer
palliative care
psychology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/thoraxjnl-2019-213879Licence: CC BY

Published versionFinal published version, 1.02 MBLicence: CC BY

Cite this

Higginson, I. J., Wilcock, A., Johnson, M. J., Bajwah, S., Lovell, N., Yi, D., Hart, S. P., Crosby, V., Poad, H., Currow, D., Best, E., Brown, S., BETTER-B Feasibility Trial Group, Higginson, I., Pullen, J., Neville, K., Hiley, V., Liversedge, V., Brown, S., ... Paine, M. (2020). Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility). Thorax, 75(2), 176-179. https://doi.org/10.1136/thoraxjnl-2019-213879

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title = "Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility)",

abstract = "New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score ≥3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated. Trial registration: ISRCTN 32236160; European Clinical Trials Database (EudraCT no: 2015-004064-11).",

keywords = "COPD exacerbations, COPD pharmacology, drug reactions, emphysema, idiopathic pulmonary fibrosis, lung cancer, palliative care, psychology",

author = "Higginson, {Irene J.} and Andrew Wilcock and Johnson, {Miriam J.} and Sabrina Bajwah and Natasha Lovell and Deokhee Yi and Hart, {Simon P.} and Vincent Crosby and Heather Poad and David Currow and Emma Best and Sarah Brown and {BETTER-B Feasibility Trial Group} and I Higginson and Jackie Pullen and Katie Neville and Victoria Hiley and Vicky Liversedge and Sarah Brown and Avie-Lee Tillotson and Natasha Lovell and Johnson, {Miriam J.} and Andrew Wilcock and David Currow and Deokhee Yi and M Paine",

note = "This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.",

year = "2020",

month = feb,

doi = "10.1136/thoraxjnl-2019-213879",

language = "English",

volume = "75",

pages = "176--179",

journal = "Thorax",

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Higginson, IJ, Wilcock, A, Johnson, MJ, Bajwah, S, Lovell, N, Yi, D, Hart, SP, Crosby, V, Poad, H, Currow, D, Best, E, Brown, S, BETTER-B Feasibility Trial Group, Higginson, I, Pullen, J, Neville, K, Hiley, V, Liversedge, V, Brown, S, Tillotson, A-L, Lovell, N, Johnson, MJ, Wilcock, A, Currow, D, Yi, D & Paine, M 2020, 'Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility)', Thorax, vol. 75, no. 2, pp. 176-179. https://doi.org/10.1136/thoraxjnl-2019-213879

Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility). / Higginson, Irene J.; Wilcock, Andrew; Johnson, Miriam J. et al.
In: Thorax, Vol. 75, No. 2, 02.2020, p. 176-179.

Research output: Contribution to journal › Article › peer-review

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AU - Higginson, Irene J.

AU - Wilcock, Andrew

AU - Johnson, Miriam J.

AU - Bajwah, Sabrina

AU - Lovell, Natasha

AU - Yi, Deokhee

AU - Hart, Simon P.

AU - Crosby, Vincent

AU - Poad, Heather

AU - Currow, David

AU - Best, Emma

AU - Brown, Sarah

AU - BETTER-B Feasibility Trial Group

AU - Higginson, I

AU - Pullen, Jackie

AU - Neville, Katie

AU - Hiley, Victoria

AU - Liversedge, Vicky

AU - Brown, Sarah

AU - Tillotson, Avie-Lee

AU - Lovell, Natasha

AU - Johnson, Miriam J.

AU - Wilcock, Andrew

AU - Currow, David

AU - Yi, Deokhee

AU - Paine, M

N1 - This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

PY - 2020/2

Y1 - 2020/2

N2 - New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score ≥3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated. Trial registration: ISRCTN 32236160; European Clinical Trials Database (EudraCT no: 2015-004064-11).

AB - New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score ≥3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated. Trial registration: ISRCTN 32236160; European Clinical Trials Database (EudraCT no: 2015-004064-11).

KW - COPD exacerbations

KW - COPD pharmacology

KW - drug reactions

KW - emphysema

KW - idiopathic pulmonary fibrosis

KW - lung cancer

KW - palliative care

KW - psychology

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U2 - 10.1136/thoraxjnl-2019-213879

DO - 10.1136/thoraxjnl-2019-213879

M3 - Article

C2 - 31915308

AN - SCOPUS:85077759661

SN - 0040-6376

VL - 75

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JO - Thorax

JF - Thorax

IS - 2

ER -

Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility)

Abstract

Bibliographical note

Keywords

UN SDGs

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